Fibromyalgia Clinical Trial
Official title:
Clinical Research, Randomized, Open, Unmasked, Controlled, Cross-group, Active-treatment, to Evaluate the Clinical Efficacy of Whole Body Cryotherapy (WBC) in the Cryosense TCT Cabin for the Treatment of Fibromyalgia
Verified date | February 2018 |
Source | Tecnología e Innovación Médico Estética S.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin. Measurement period time: 8 weeks.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 9, 2017 |
Est. primary completion date | June 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age between 25 and 80 years old - Diagnosis of Fibromyalgia according to ACR criteria - More than 1 year from diagnosis - Lack of response or partial response to previous treatment - In case of women,commitment not to get pregnant during the study. Exclusion Criteria: - Patiens with cardiovascular or psychiatric comorbidity - Cold intolerance - Changes in pharmacological treatment during the study - Body temperature over 37,5ºC |
Country | Name | City | State |
---|---|---|---|
Spain | Tecnología e Innovación Médico Estética | Madrid |
Lead Sponsor | Collaborator |
---|---|
Tecnología e Innovación Médico Estética S.L. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia Impact Questionnaire (FIQ) | This instrument composed of 10 items, measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. | 8 weeks | |
Secondary | Combined Index of Severity of Fibromyalgia (ICAF) | Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping | 8 weeks | |
Secondary | General health questionnaire (SF36) | It´s composed of 36 questions (items) that assess both positive and negative health states | 8 weeks | |
Secondary | Pain intensity measure. Visual Analogyc scale (VAS) | Each patien marks in the scale the pain intensity scored 0-10 (0= no pain; 10= pain as can be) | 8 weeks |
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